A client of ours is looking to bring on a Senior Regulatory Affairs Specialist to work on cutting edge Class II and Class III medical devices.

Essential Requirements

• 4+ years of Regulatory Affairs Experience in the Medical Device space
• Experience as lead author on a major FDA submission (510k or PMA preferred)
• B.S in Biology, Chemistry, Biomedical Engineering or a similar field
• U.S Ad/Promo experience
• International regulatory experience (LATAM, EU, APAC, Health Canada)
• Preference given to candidates based in Massachusetts, but candidates can be based anywhere in the United States, this role is remote